Foghorn Therapeutics(FHTX) - 2024 Q3 - Quarterly Results

Corporate and Financial Update Foghorn Therapeutics achieved significant clinical milestones and strengthened its financial position with a substantial cash runway into 2027 Key Highlights and Corporate Updates Foghorn Therapeutics advanced its clinical pipeline with key dosing and data milestones, while bolstering its financial and leadership teams - Dosed the first patient with the first-in-class SMARCA2 selective inhibitor FHD-909 in a Phase 1 trial targeting SMARCA4 mutated non-small cell lung cancer (NSCLC)[1][4] - Expects to release topline Phase 1 dose escalation data for FHD-286 combined with decitabine in relapsed/refractory AML by the end of 2024[1][2] - IND-enabling studies for the Selective CBP degrader program are on track to commence by the end of 2024[1][2] - Strengthened executive leadership with the appointment of Anna Rivkin, Ph.D., as Chief Business Officer[5] Financial Position as of September 30, 2024 | Metric | Value | | :--- | :--- | | Cash, cash equivalents, and marketable securities | $267.4 million (as of Sep 30, 2024) | | Expected Cash Runway | Into 2027 | Program Overview and Upcoming Milestones This section details the progress and future milestones for Foghorn's key therapeutic programs, including FHD-286, FHD-909, and degrader initiatives FHD-286 (SMARCA2/4 Inhibitor) FHD-286, a first-in-class SMARCA2/4 inhibitor, is undergoing a Phase 1 trial in AML, with topline data expected by year-end - FHD-286 is a potent, first-in-class, selective inhibitor of SMARCA2 (BRM) and SMARCA4 (BRG1)[6] - A Phase 1 dose escalation trial is currently evaluating FHD-286 in combination with decitabine or low-dose cytarabine in patients with relapsed and/or refractory AML[6] - Topline data on safety, tolerability, initial efficacy, and PK/PD are anticipated by the end of 2024[6] FHD-909 (Selective SMARCA2 Inhibitor) FHD-909, a selective SMARCA2 inhibitor, has begun Phase 1 trials for SMARCA4 mutated cancers under a strategic collaboration with Lilly - FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that employs a synthetic lethal strategy against tumors with SMARCA4 mutations[7] - The first patient was dosed in October 2024 in a Phase 1 trial for SMARCA4 mutated cancers, with NSCLC as the primary target population[4][7] - The program is part of a strategic collaboration with Lilly, which includes a U.S. 50/50 co-development and co-commercialization agreement and other discovery programs[7] Selective CBP/EP300 Degrader Programs Foghorn is advancing two distinct degrader programs targeting CBP and EP300, with IND-enabling studies for the Selective CBP degrader on track - Selective CBP Degrader: On track to initiate Investigational New Drug (IND)-enabling studies by Q4 2024 to target tumors with EP300 mutations (e.g., bladder, gastric, endometrial cancers)[8][9] - Selective EP300 Degrader: Preclinical data showed robust anti-tumor activity in CBP mutant and EP300-dependent cancers, including prostate cancer and multiple myeloma, and was well-tolerated in vivo with no observed decrease in platelet levels[9] Selective ARID1B Degrader Program This program targets ARID1A-mutated cancers by developing selective ARID1B degraders, leveraging a synthetic lethal dependency - The program targets the dependency on ARID1B in cancers with ARID1A mutations, found in ovarian, endometrial, colorectal, and bladder cancers[10] - The company has developed potent and selective small molecule binders to ARID1B and is in the process of converting them into degraders[10] Third Quarter 2024 Financial Highlights Foghorn's Q3 2024 financial results reflect decreased collaboration revenue and lower operating expenses, impacting net loss Financial Performance Summary Q3 2024 saw a decrease in collaboration revenue and operating expenses, leading to an increased net loss compared to the prior year Q3 Financial Performance Summary | Financial Metric (Q3) | 2024 | 2023 | Reason for Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $7.8M | $17.5M | Decrease due to end of Merck collaboration in Aug 2023 | | R&D Expenses | $24.7M | $26.3M | Decrease due to increased Lilly partnered programs and lower personnel costs | | G&A Expenses | $7.0M | $8.3M | Decrease primarily due to lower personnel-related costs | | Net Loss | ($19.1M) | ($14.3M) | Loss increased due to lower revenue, partially offset by lower expenses | Cash Position and Runway Foghorn maintains a robust cash position of $267.4 million as of September 30, 2024, providing an operational runway into 2027 - The company had $267.4 million in cash, cash equivalents, and marketable securities as of September 30, 2024[14] - This cash position provides an expected runway into 2027[14] Financial Statements This section presents Foghorn's condensed consolidated balance sheets and statements of operations for the reported periods Condensed Consolidated Balance Sheets As of September 30, 2024, total assets were $308,372 thousand, with a reduced stockholders' deficit of $28,287 thousand compared to year-end 2023 Condensed Consolidated Balance Sheets (In thousands) | (In thousands) | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash, cash equivalents and marketable securities | $267,397 | $234,057 | | Total assets | $308,372 | $285,916 | | Liabilities and Stockholders' Deficit | | | | Deferred revenue, total | $282,919 | $302,665 | | Total liabilities | $336,659 | $363,106 | | Total stockholders' deficit | $(28,287) | $(77,190) | | Total liabilities and stockholders' deficit | $308,372 | $285,916 | Condensed Consolidated Statements of Operations For Q3 2024, Foghorn reported a net loss of $19,122 thousand, or ($0.31) per share, primarily due to decreased collaboration revenue Condensed Consolidated Statements of Operations (In thousands, except per share data) | (In thousands, except per share data) | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Collaboration revenue | $7,808 | $17,478 | | Research and development | $24,689 | $26,251 | | General and administrative | $6,971 | $8,308 | | Total operating expenses | $31,660 | $34,559 | | Loss from operations | $(23,852) | $(17,081) | | Net loss | $(19,122) | $(14,345) | | Net loss per share—basic and diluted | $(0.31) | $(0.34) | | Weighted average common shares outstanding | 62,602,848 | 42,025,938 |